Iqra Hussain

Skills

Pharmacovigilance & Drug Safety

Case processing, triage, and adverse event reporting
Knowledge of GVP and global pharmacovigilance regulations
Safety data validation and quality assurance

Technical & Systems Skills

Argus Safety Database
MedDRA coding
Proxi system
Clinical trial pharmacovigilance support

Medical Writing & Communication

Scientific and medical content writing
Translating complex clinical data into clear, accessible information
Critical appraisal of scientific literature
SEO and digital health content optimisation

Analytical & Problem-Solving

Data analysis and interpretation
Identifying inconsistencies and improving processes
Attention to detail and accuracy

Regulatory & Compliance

SOP adherence and compliance monitoring
Documentation and audit readiness
Understanding of regulatory frameworks

Communication & Interpersonal Skills

Cross-functional collaboration
Customer service and stakeholder communication
Handling sensitive and high-pressure situations with professionalism

Organisation & Leadership
Time management and meeting deadlines
Training and mentoring new staff
Workflow coordination and process improvement

About

Detail-oriented Pharmacovigilance & Medical Writing Professional with 4+ years’ experience in drug safety, case triage, clinical trial support, and regulatory documentation within global pharmacovigilance environments.
Demonstrates strong expertise in GVP compliance, MedDRA coding, and safety databases including Argus and Proxi, ensuring high-quality data accuracy, timely reporting, and inspection readiness.
Proven track record in Clinical Evaluation Report (CER) authoring, having independently completed 4 CERs and contributed to 8–10 reports, supporting regulatory submissions and post-market surveillance.
Skilled in medical writing and scientific communication, producing clear, evidence-based, and regulatory-aligned content, further strengthened through a Scientific Medical Writing internship.
Recognised for driving process efficiency, maintaining compliance in regulated environments, and applying analytical problem-solving to complex safety data.
Holds an MSc in Criminal Investigation and BSc in Forensic Science, bringing advanced strengths in risk assessment, investigation, and data analysis to pharmacovigilance and regulatory practice. Demonstrates a strong interest in Counterterrorism, supported by a research project with Cleveland Police analysing the Prevent Strategy within a Muslim community in Northeast England.